BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7751181 · Received August 6, 2018

    Report

    Report Number
    3009185973-2018-00212
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 2, 2018
    Report Date
    January 24, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE KINEVERIF TEST FAILED. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A REQUEST FOR PRODUCT RETURN HAS BEEN PERFORMED FOR INVESTIGATION OF THESE INSTRUMENTS HOWEVER THEY WERE LOST DURING SHIPMENT TO MEDTECH / ZIMMER BIOMET THEREFORE INVESTIGATION WAS IMPOSSIBLE. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. UDI# (B)(4).

    Description of Event or Problem · 0

    DURING THE PREVENTIVE MAINTENANCE THE DISTRIBUTOR WAS NOT ABLE TO PASS THE OFFSET CALIBRATION THROUGH KINEVERIF. IT COULD BE AN INACCURACY FROM THE LASER OR THE LASER OFFSET PLATE HAS BEEN BENDED. THE LASER AND THE OFFSET PLATE ARE STORED IN THEIR ORIGINAL PACKAGING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.  THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359/K172444.

    Description of Event or Problem · 1

    DURING THE PREVENTIVE MAINTENANCE THE DISTRIBUTOR WAS NOT ABLE TO PASS THE OFFSET CALIBRATION THROUGH KINEVERIF. IT COULD BE AN INACCURACY FROM THE LASER OR THE LASER OFFSET PLATE HAS BEEN BENDED. THE LASER AND THE OFFSET PLATE ARE STORED IN THEIR ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592644 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA OPTICAL DISTANCE SENSOR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1